BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.85MM TI MATRIX SCREW SELF-DRILLING/6MM

    MDR report key: 6027263 · Received October 13, 2016

    Report

    Report Number
    1719045-2016-10757
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    August 31, 2016
    Report Date
    September 16, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JEY
    PMA / PMN Number
    K083388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE TRUE AWARE DATE IS (B)(6) 2016. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE BROKE INTRA-OPERATIVELY AND WAS NOT IMPLANTED OR EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT: MANUFACTURING LOCATION: (B)(4) / US, MANUFACTURING DATE: 20TH JULY 2016, EXPIRY DATE: 1ST JULY 2026, ARTICLE WAS STERILIZED BY SUPPLIER (B)(4) WITH LOT NUMBER L070236. ARTICLE 04.511.226.01C WAS MANUFACTURED IN THE US WITH LOT NUMBER H134357. MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: 27-JUN-2016. PART #: 04.511.226.01C, LOT#: H134357 (NON-STERILE) - 1.85MM TI MATRIX SCREW SELF-DRILLING/6MM. QUANTITY 120. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE RECEIVED BY MANUFACTURER WAS POPULATED AS NOV 16, 2916 IN SUPPLEMENTAL MEDWATCH #(B)(4). THE CORRECT DATE WAS NOV 16, 2016. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY FOR MAXILLARY AND MANDIBULAR OSTEOTOMY ON (B)(6) 2016, THE HEAD OF THE LOCKING SCREW (MATRIX SCREW Ø 1.85MM, SELF-DRILLING, L 6MM) WAS BROKEN. ANOTHER LOCKING SCREW (MATRIX LOCK SCREW Ø 1.85MM, SELF-DRILLING, L 6MM) WAS ALREADY FIXED BUT IT WAS REMOVED TOGETHER TO TAKE OUT THE REMAINING SHAFT PART OF THE BROKEN LOCKING SCREW. THE SURGEON TRIED TO FIX THE PLATE ONCE AGAIN BY INSERTING THE SCREW (MATRIX LOCK SCREW Ø 1.85MM, SELF-DRILLING, L 6MM), HOWEVER IT DID NOT WORK. ANOTHER SCREW WAS USED TO COMPLETE THE CASE. THIS COMPLAINT INVOLVES 1 PARTS. CONCOMITANT PART: PLATE (MAXILLARY, MANDIBULARY) (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680423 1.85MM TI MATRIX SCREW SELF-DRILLING/6MM BONE PLATE JEY SYNTHES SELZACH L070236

    Patients

    Seq Age Sex Outcome Treatment
    1 PLATE (MAXILLARY, MANDIBULARY) (PART: UNK, LOT UNK